Kornimate/medical-research-clean huggingface dataset:
tdcs in pediatric acquired brain injury

Conditions: Acquired Brain Injury; Disorders of Consciousness

Summary: in this preliminary study, we will examine the safety, tolerability, and feasibility of transcranial direct current stimulation (tdcs), in the setting of dosage escalation, as a candidate intervention for children with acquired brain injury (abi).

previous studies have demonstrated that transcranial direct current stimulation (tdcs) is safe and effective in adults with chronic acquired brain injury. limited data have established the safety of tdcs in children with neuropsychiatric and neuromotor disorders. however, these tdcs safety paradigms may not be relevant to children with abi due to their abnormal brain structure and function, decreased ability to communicate, variable symptomology, and time-consuming care needs that exist in this population. in this open-label, single-group, dosage escalation study, investigators aim to assess the safety, tolerability, and feasibility of incrementally higher tdcs currents in 10 pediatric patients with abi on an inpatient rehabilitation unit. the study will include up to three sessions of tdcs (sham, 1ma, and then 2 ma) either over the left dorsolateral prefrontal cortex or over the primary motor cortex based on the goal to evaluate change in either cognitive or motor function. we will also explore whether tdcs improves consciousness in pediatric doc. mozart classical music, as a concurrent intervention, will be played during sham, 1 ma, and 2 ma tdcs applications.

Eligibility criteria:
inclusion criteria: * age 5 through 17 years * history of acquired brain injury. * currently inpatient at the kennedy krieger rehabilitation unit. * parent and child proficient in english. exclusion criteria: * patients with extensive focal lesions in the left dorsolateral prefrontal cortex (dlpfc) and bilateral primary motor cortex as determined by review of imaging and/or imaging reports obtained as part of clinical care. * youth with known seizures in the month prior to study enrollment. * participants with non-convulsive seizures and/or interictal epileptiform discharges observed on study screening extended eeg. * females with confirmed pregnancy on urine test. * youth with history of craniotomy surgery, metallic cerebral, cochlear or electronic implant in the head or neck area, or ventricular shunt or pacemaker. * patients requiring daytime mechanical ventilation. * children with head circumference less than 43 cm * bilateral severe or profound hearing loss * presence of hairstyle interfering with tdcs application and/or high quality eeg signal * youth in foster care.

Keywords: acquired brain injury transcranial direct current stimulation pediatric safety feasibility
study evaluating the safety and efficacy of a once-daily dose of tigecycline vs ertapenem in diabetic foot infections (dfi) with a substudy in patients with diabetic foot infections complicated by osteomyelitis.

Conditions: Bacterial Infections; Diabetic Foot; Osteomyelitis

Summary: the purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. the co-primary efficacy endpoints were not met.


Eligibility criteria:
main inclusion criteria: * men and women aged 18 or older with diabetes and a qualifying foot infection. people with evidence of a diabetic foot infection with osteomyelitis may qualify for the osteomyelitis substudy arm. main exclusion criteria: * people with additional significant disease, infection with resistant pathogens, contraindication, or hypersensitivity to any test article or related antibiotic.

Keywords: diabetic foot infection osteomyelitis diabetes complications foot ulcer skin infection
bar as a mortality predictor in septic aki

Conditions: Acute Kidney Injury; Sepsis

Summary: the aim of this study is to investigate the prognostic value of blood urea nitrogen to serum albumin ratio in septic acute kidney injury patients follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.

a complete medical history will be obtained from all patients including age, sex, comorbidities, cause of sepsis, and sofa and apache ii scores at admission. blood samples will be collected within 24 hours of aki diagnosis for analysis of blood urea nitrogen (bun) and serum albumin levels. blood urea nitrogen to serum albumin ratio (b/a) will be calculated by dividing the bun of a patient by their serum albumin levels. laboratory parameters also will include ph, lactate (lac), base excess (be), hemoglobin (hb), platelet (plt) count, white blood cell (wbc) count, bilirubin, hematocrit (hct), creatinine (cr), serum sodium (na), serum potassium (k), serum calcium (ca), serum magnesium (mg), triglyceride (tg), aspartate aminotransferase (alt), alanine aminotransferase (ast), prothrombin time (pt), and activated partial thromboplastin time (aptt) values. follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death. study population will be divided into survival and non-survival groups based on their 30-day survival status

Eligibility criteria:
inclusion criteria: 1. 18 - 60 years of age 2. fulfilled the diagnostic criteria of sepsis 3.0 (defined as a suspected or confirmed infection with a sequential organ failure assessment (sofa) score of 2 or higher) 3. developed aki during hospitalization according to kidney disease: improving global outcomes (kdigo) guideline exclusion criteria: 1. icu length of stay\<24 h 2. aki occurred before current hospital admission. 3. aki is supposed to be secondary to causes other than sepsis. 4. receiving renal replacement therapy at the time of admission. 5. diagnosis with chronic kidney disease. 6. diagnosis with liver failure. 7. pregnant or lactating. 8. there was insufficient data for analysis. 9. patients who had received human serum albumin infusion 3 days before icu admission.
artificial intelligence in endometriosis-related ovarian cancer and precision surgery in endometriosis-related ovarian cancer

Conditions: Patients With Suspected Ovarian Carcinoma; Non Oncological Patients or With Endometriosis

Summary: endometriosis (ems) is a chronic, invaliding, inflammatory gynaecological condition affecting 10-15% of women in reproductive age. ems is characterized by lesions of endometrial-like tissue outside the uterus involving pelvic peritoneum and ovaries. in addition, distant foci are sometimes observed. unfortunately, the aetiology of the ems is little known. although non-malignant, ems shares similar features with cancer, such as development of local and distant foci, resistance to apoptosis and invasion of other tissues with subsequent damage to the target organs. moreover, patients with ems (particularly ovarian ems) showed high risk (about 3 to 10 times) of developing epithelial ovarian cancer (eoc). epidemiologic, morphological and molecular studies reported endometrioma as the precursor of eoc, including clear cell (ccc) endometrioid carcinoma which are both called "ems-related ovarian carcinoma (eroc)". to date, it remains unclear why benign ems causes malignant transformation. this multi-step process, unlike high-grade serous carcinomas, offers the possibility to identify the carcinoma precursors enabling an early diagnosis and in the early stages of the disease. eoc is the most lethal female gynecological cancer with 25% 5-year overall survival (os), due to the lack of effective screening tools, and rapidly spreads over the entire peritoneal surface (carcinosis) thus involving all abdominal organs. diagnosis and clinical staging of eoc is currently performed by qualitative image evaluation although the sensitivity/specificity is suboptimal. to date, diagnostic, staging, and prognostic factors are strongly correlated with subjective assessment training and clinician experience. genomic analysis based on next generation sequencing (ngs) has revealed the presence of cancer-associated gene mutations in ems. moreover, the chronic inflammatory process of ems involves many factors, such as hormones, cytokines, glycoproteins, and angiogenic factors, which are expected to become early ems biomarkers. a promising new branch of cancer research is the use of artificial intelligence (ai) to recognize new image patterns and texture and/or detecting novel biomarkers to improve the early identification of eroc patients. ai has never been used for eroc and we want to investigate whether these methods/techniques can support and even improve current diagnostics and risk assessment. ai will be used to construct a new 3d risk assessment model based on images and volume of interest


Eligibility criteria:
inclusion criteria: * age\>18 * suspected diagnosis of epithelial ovarian cancer * patients eligible for surgery * radiological imaging available * informed consent exclusion criteria: * patients with previous different malignancies * patients with previous chemotherapeutic treatment * patients with previous pelvic radiotherapeutic treatment

Keywords: endometriosis ovarian cancer artificial intelligence
whatsapp in india during the covid-19 pandemic

Conditions: Covid19

Summary: digital misinformation has been flagged as a major risk of the 21st century, with an estimated cost of $78 billion to the global economy each year. given this scope, we propose to characterize how misinformation is spread via messenger platforms (e.g. whatsapp). specifically, we seek to: 1. identify metrics of potential misinformation (aim 1). this is based on the hypothesis that although message contents are highly private, proxy markers can be used to identify potential misinformation. 2. understand the base-rate by which misinformation is shared via messaging applications (aim 2). this is founded on the hypothesis that misinformation is endemic on messaging platforms, and thus needs to be documented. 3. identify "super spreaders" responsible for sending and receiving a large volume of misinformation (aim 3). here, we hypothesise that a small group of super spreaders are responsible for the bulk of misinformation-sharing on messaging applications. the thrust of this work aligns with both government priorities and the grant's thematic areas, providing actionable findings that are timely amidst a worldwide surge of misinformation.


Eligibility criteria:
inclusion criteria: * lived in india for more than 2 years, * currently living in india * owns a whatsapp account exclusion criteria: * not currently living in india * below the ages of 21 * has not lived in india for more than 2 years * does not own a whatsapp account * does not speak english or hindi

Keywords: whatsapp misinformation rumours india experience sampling
iron status and human metabolism

Conditions: Iron Deficiency

Summary: iron deficiency is common in cardiorespiratory diseases and appears to contribute to a worse outcome. this human physiology study will examine the extent to which human skeletal muscle metabolism and exercise physiology are impaired by iron deficiency.

this is a prospective double-blind randomised controlled study of the effect of endogenous iron status on skeletal muscle metabolism and exercise physiology. 32 healthy volunteers will take part, half of whom will be iron-deficient. the study involves a screening visit and two half-day visits during which assessments are performed. 50% of each group will be randomised to receive iron-repletion with ferric carboxymaltose at the end of the first experimental visit before returning to repeat identical assessments around one week later. this approach will make it possible to explore whether baseline differences in skeletal muscle metabolism are explained by differences in iron status per se, whilst controlling for any learning effect during participation in the study.

Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the study * men and women aged 18 years or older and generally in good health * for iron-deficient volunteers: ferritin ≤ 15 microg/l and transferrin saturation \< 16% * for iron-replete volunteers: ferritin ≥ 20 microg/l and transferrin saturation ≥ 20% exclusion criteria: * haemoglobin \< 8.0 g/dl * haemoglobinopathy * iron overload, defined as ferritin \> 300 microg/l * hypoxaemia (spo2 \< 94%) or significant co-morbidity that may affect haematinics, metabolic or ventilatory responses * iron supplementation or blood transfusion within the previous 6 weeks * pregnancy or breast feeding * inability to exercise isolated calf muscle using a pedal or on a bicycle ergometer * contraindication to magnetic resonance spectroscopy exposure such as metallic implant * contraindication to receiving intravenous ferric carboxymaltose
relative bioavailability of two formulations of akb-6548 and the food effect of a new tablet in healthy adult subjects

Conditions: Healthy

Summary: the primary purpose of this study is to compare the pk parameters of a single dose of a test tablet formulation of akb-6548 relative to a single dose of the reference akb-6548 tablet formulation, both treatments administered without food, and to compare the pk parameters of the test tablet formulation given under fed and fasted conditions.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive. exclusion criteria: * current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease. * positive serology results for hbsag, hcv, and hiv at screening. * significant renal impairment as evidenced by an estimated glomerular filtration rate (egfr) of \<65 ml/min * known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months. * current or past history of gastric or duodenal ulcers or other diseases of the gi tract (including gastric bypass surgeries) that could interfere with absorption of study drug. * subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months.

Keywords: pharmacokinetics anemia chronic kidney disease ckd renal impairment chronic renal insufficiency ferrous sulfate iron end stage renal disease dialysis oral anemia treatment bioavailability erythropoietin hypoxia-inducible factor volunteers
prospective, randomized, multicenter study to assess the safety and effectiveness of the orsiro sirolimus-eluting stent

Conditions: Coronary Artery Disease

Summary: bioflow-iv is a prospective, international, multicenter, randomised controlled trial. the purpose of this trial is to compare the biotronik orsiro drug eluting stent system with the xience prime / xience xpedition (xience)drug eluting stent system in de novo coronary lesions. the study is powered for non-inferiority with respect to target vessel failure(tvf)at 12 months.


Eligibility criteria:
main inclusion criteria: * subject must provide written informed consent * the target reference vessel diameter (rvd) is ≥ 2.50 mm and ≤ 3.75 mm assessed either visually or by online qca. * target lesion length is ≤ 26 mm (assessed either visual estimate or by online qca) and can be covered by one study stent * single de novo lesion with ≥ 50% and \< 100% stenosis in up to 2 coronary arteries main exclusion criteria: * subject has evidence of myocardial infarction within 72 hours prior to the index procedure * planned intervention of non-target vessel(s) within 30 days after the index procedure * planned intervention of target vessel(s) after the index procedure * target lesion is located in the left main * target lesion is located in or supplied by an arterial or venous bypass graft * target lesion involves a side branch \> 2.0 mm in diameter by visual estimate or by online qca * proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off
accuracy of digital implant impression

Conditions: Edentulous Jaw

Summary: this study aims to investigate the accuracy of complete-arch digital implant impression using newly designed scan bodies with extensional structure.

fully edentulous patients with 2-6 dental implants are included in this study. for each patient, the follow three impressions are made: conventional splinted open-tray impression, digital impression using scan bodies without extensional structure, and digital impression using scan bodies with extensional structure. the accuracy of the three impressions is compared in an inspection software.

Eligibility criteria:
inclusion criteria: * at least 18 years old and able to understand an informed consent * fully edentulous jaw * 2-6 dental implants have been placed in the edentulous jaw * the implants have been osseointegrated * mouth opening larger than 4.5 cm exclusion criteria: * poor oral hygiene * presence of peri-implantitis or peri-implant mucositis * presence of temporamandibular joint disease * unwilling to paticipate in the research

Keywords: dental implant digital impression scan body accuracy
study on reduced antibiotic treatment vs broad spectrum betalactam in patients with bacteremia by enterobacteriaceae

Conditions: Enterobacteriaceae Infections

Summary: the continuous increase in the bacterial resistance rate and the slow arrival of new therapeutic options have turned into an antibiotic crisis. one of the strategies proposed by stewardship programs to try to change this situation described worldwide is the use of antibiotics with the lowest possible antimicrobial spectrum. enterobacteriaceae bacteremia is a good example of how this strategy would be applied. the empirical treatment of nosocomial bacteremia by enterobacteriaceae comprises in several cases one or two antibiotics with antipseudomonal activity, being much less common than desirable a subsequent change to narrower spectrum antibiotics based on susceptibility data ("de escalation"). this is because the safety of de escalation is based only on expert advice and some observational studies, so their efficacy and safety is questioned by many clinicians and therefore its use is lower than desired. in fact, a recent systematic review of the cochrane library concluded that randomized studies to support this practice are needed. investigators propose a "real clinical practice-based" randomized trial to compare the efficacy and safety of continuing with an antipseudomonal agents vs. de-escalation according to a pre-specified rule, in patients with bacteraemia due to enterobacteriaceae.


Eligibility criteria:
inclusion criteria: 1. ≥18 years old hospitalized patients with bacteremia from any source with isolation of an enterobacteria in blood cultures. 2. active empiric treatment with antipseudomonal betalactamic at 48 hours from the symptoms of sepsis and the blood culture.the patient could have received any other type of antibiotic therapy up to 24 hours after blood extraction. 3. microorganism susceptible at least one treatment from the experimental arm. 4. patients with intravenous treatment at least 3 days from the randomization o 5 days from the initial blood culture. 5. patients to sign the informed consent form. exclusion criteria: 1. palliative care or life expectance \< 90 days. 2. pregnancy or lactation period. 3. to isolate the extended-spectrum β-lactamases producing enterobacteriaceae 4. late randomization \>48 hours after the enterobacteriaceae blood culture´s identification 5. severe neutropenic (\< 500 céls/mm3) at the randomization. 6. treatment of infection \> 28 days (endocarditis and osteomyelitis) or meningitis.

Keywords: enterobacteriaceae bacteremia escalation bacterial resistance bloodstream infection recurrence
feasibility of one-step sentinel lymph node (sln) biopsy with radiolabeled methylene blue (ind 70,627)

Conditions: Breast Cancer

Summary: the purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.

this study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). on the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. the injection will be in the location around the breast tumor. the surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. these lymph nodes are then removed and analyzed by pathologists for the presence of cancer.

Eligibility criteria:
inclusion criteria: * stage 0,i, ii breast cancer * clinical node status n0, n1 * no know allergy to iodine, lymphazurin or methylene blue dyes exclusion criteria: * patient cannot be pregnant or nursing * prisoners will not be eligible * women under the age of 18 will not be eligible * patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes

Keywords: breast cancer diagnostic lymph nodes
robotic-assisted esophagectomy vs. video-assisted thoracoscopic esophagectomy(revate) trial

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.

radical lymph node dissection (lnd) along the recurrent laryngeal nerve (rln) is surgically demanding and can be associated with substantial postoperative morbidity. the question as to whether robot-assisted esophagectomy (re) might be superior to video-assisted thoracoscopic esophagectomy (vate) for performing lnd along the rln in patients with esophageal squamous cell carcinoma (escc) remains open. the investigators will conduct a multicenter, open-label, randomized controlled trial (termed revate) enrolling patients with escc scheduled to undergo lnd along the rln. patients will be randomly assigned to either re or vate. the primary outcome measure will be the rate of unsuccessful lnd along the left rln, which will be defined as 1) failure to remove lymph nodes along the left rln or 2) occurrence of left rln palsy following lnd. secondary outcomes will include the number of successfully removed rln nodes, postoperative recovery, length of hospital stay, 30- and 90-day mortality, quality of life, and oncological outcomes.

Eligibility criteria:
inclusion criteria 1. age between 18\~80 2. histologically proven primary intrathoracic esophageal squamous cell carcinoma and will undergo mckeown mie and bilateral rln lnd. 3. patients should have a performance status 0, 1 or 2 according to the european clinical oncology group. 4. surgical resectable(ct1\~4a, n0\~3, m0) 5. written informed consent exclusion criteria are 1. previous major thoracic surgery rendering minimal invasive approach unfeasible 2. prognosis determining malignancy other than esophageal cancer, inability to undergo curative resection and/or follow-up 3. inability to provide oral or written informed consent. 4. pre-existed vocal cord dysfunction will also be excluded.

Keywords: robotic esophagectomy video-assisted thoracoscopic esophagectomy recurrent laryngeal nerve lymh node esophageal squamous cell carcinoma